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Teratogen Update: Reproductive Risks of Leflunomide (Arava™); a Pyrimidine Synthesis - page 3 / 21





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Pregnancy must be excluded before the start of treatment with Arava™. Arava™ is contraindicated in pregnant women, or women of childbearing potential who are not using reliable methods of contraception.  Pregnancy must be avoided during Arava™ treatment  or prior to the completion  of the drug elimination procedure after Arava™ treatment.

Use in Women of Childbearing Potential

There are no adequate and well-controlled studies evaluating Arava™  in pregnant women. However, based on animal studies, leflunomide may increase the risk of fetal death or teratogenic effects when administered to a pregnant woman. Women of childbearing  potential must not be started on Arava™  until pregnancy is excluded and it has been confirmed that they are using reliable contraception.   The patient must be advised that if there is a delay in the onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and the patient must discuss the risk of pregnancy.  It is possible that rapidly lowering the blood level  of the active  metabolite, by instituting the drug elimination  procedure  described below, at the first delay of menses, may decrease the risk to the fetus from Arava™ .

Upon discontinuing Arava™, it is recommended  that all women of childbearing potential undergo the drug elimination  procedure described below.  Women receiving Arava™ treatment who wish to become pregnant  must discontinue Arava™ and undergo the drug elimination  procedure described below, which includes verification of M1 metabolite plasma levels less than 0.02 mg/L (0.02 g/ml).  Human plasma levels of the active metabolite (M1) less than 0.20 mg/L (0.02 g/ml)  are expected to have minimal risk based on available animal data.

Drug Elimination Procedure

The following drug elimination procedure is recommended to achieve non-detectable plasma levels less than 0.02 mg/L (0.02 g/ml)  after stopping drug treatment with Arava™:

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